The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms

Summary

Prospective multi-center single arm study of large or giant intracranial aneurysms with a wide neck in which subjects will be imlanted with the Surpass Flow Diverter. Patients who have been referred to the investigators and who meet the study inclusion/exclusion criteria will be invited to participate. Subjects will be allowed to review the informed consent for a minimum of 24 hours. Subjects who agree to participate will undergo the following:

Participant Eligibility

1. Age 19 to 80 years
2. Subject or legal representative is willing and able to give informed consent
3. Subject has a single targeted intracranial aneurysm that:
a. Is located in the internal carotid artery (ICA) distribution up to the terminus
b. Is able to be crossed with a standard 0.014
* guide wire
c. Has a neck >4 mm or no discernible neck and an aneurysm size >10 mm (including saccular, fusiform and dissecting configuration)
d. Has a vessel diameter between 2.5 mm and 5.3 mm at both the proximal and distal segments where the implant will be placed
4. Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up